Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

Not Applicable

Recruiting

• Conditions: Periodontal Diseases; Simvastatin; Photodynamic Therapy
• Interventions: Procedure: SMV application; Procedure: SMV and antimicrobial photodynamic therapy

• Registration Number: NCT05031923
• Lead Sponsor: Kafrelsheikh University

Brief Summary

Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-02
• Study Start: 2021-10-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients were all healthy and free from any systemic disease;
• no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study;
• patients were willing and able to return for multiple follow-up visits;
• good levels of oral hygiene

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Exclusion Criteria

• Pregnant and lactating female patients,
• smokers,
• alcoholics,
• those receiving any medication that could affect healing of soft or hard tissue

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMV application	SMV application	Application SMV in intrabony defect
SMV and antimicrobial photodynamic therapy	SMV and antimicrobial photodynamic therapy	Application SMV and antimicrobial photodynamic therapy in intrabony defect

Primary Outcome Measures

Name	Time	Method
Clinical evaluation and measurements of the defect in millimeters	9 months	Changes in clinical measurements after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
Radiographic evaluation and measurements of the defect in millimeters	9 months	Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters

Trial Locations

Locations (1)

Faculty of Dentistry, Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Egypt